LifeBond's surgical sealant kit receives FDA IDE approval: 4 things to know

LifeBond received FDA Investigational Device Exemption approval to begin a clinical study of the LifeSeal Surgical Sealant Kit, which includes a gastrointestinal sealant.

Here are four things to know:

1. The GI sealant is designed to minimize staple-line leakage in gastrointestinal resection procedures.

2. The FDA trial will be a multi-center, multinational, randomized, double-arm, single-blind study.

3. There will be study sites in both the Unites States and Europe.

4. The LifeSeal Surgical Sealant Kit has received the CE Mark.

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